Mexico

Clinical Trial Application	Mexico Clinical Trial Quote Request
Mandated Coverage	Yes
Standard Limits	n/a
Tail Coverage	n/a
Data Required to Quote	THE PROCESS IN MEXICO IS SLOW. PLEASE ALLOW UP TO TWO MONTHS FOR DOCUMENTS TO BE PROCESSED. Please provide all documentation outlined below otherwise the process is further delayed. PLEASE PROVIDE THE FOLLOWING INFORMATION • Clinical Trial Quote Request • Protocol and Informed Consent Form in English and Spanish • Protocol Title in Spanish • The following documents to be provided by the Sponsor: (i) Copy ID of the legal representative of the Sponsor (this should be the same as the person completing the form) (ii) Proof of address of the sponsor (not older than 3 months) (iii) Document confirming the legal establishment of the sponsor ---> Legal representative details of the Sponsor in Mexico Note the Legal Representative will be responsible for providing the following documents: (i) Copy of the Memorandum of Association registered upon the Property & Commerce Public registry (ii) Copy of the Fiscal Identification Schedule (RFC) (iii) Copy of an Official Identification and Notary’s Testimony of the local CRO (iv) Copy of a Domicile Voucher

Clinical Trial Application	Belarus Clinical Trial Quote Request Clinical Trials Quote Request
Mandated Coverage	Yes. Only one state insurance carrier in Belarus.
Standard Limits	20.000 €/patient Limit per protocol = 20.000 x number of patients
Tail Coverage	n/a
Data Required to Quote	• Clinical Trial Quote Request • LAST Protocol and Informed Consent Form in Russian • Patient Information Sheet in Russian • Investigator Brochure in Russian • Local CRO details (Contact Person Name, Address, Telephone Number and E-Mail Address) • Sponsor Banking Details or Premium Wire Confirmation • Three (3) years of claims history for harm caused or reimbursement of injured parties while carrying out clinical studies in Belarus. If no claims, please provide the following on your company letterhead, signed and dated: "We confirm that in the last three years (name of Sponsor) did not incur any claims related to clinical trials." • Site List of clinical sites in Belarus, if the MoH approval letter is unavailable Please allow additional time for processing. Typically up to 3 weeks for issuance of documents Belarus requires payment and payment confirmation documentation PRIOR to release of certificate. No refund for policy cancellation. A letter of guarantee can be provided in order to obtain the necessary MoH approval.